Severable support for a stent

ABSTRACT

A stent with at least one severable supporting device and methods of coating using the same are disclosed. The severable supporting device can be an end tube or a tab attached to some portion of the stent by at least one “gate” or attachment. The end tube or tab may be part of the design of the stent when it is originally manufactured, or it may be attached to the stent in a secondary process by a biocompatible glue or solder. The end tube or tab can be used to support a stent during a coating process eliminating the need for a mandrel which would otherwise contact the stent during the coating process.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. Ser. No.11/302,488, Severable Support for a Stent, filed on Dec. 12, 2005, andthe entire text of which is hereby incorporated by reference.

BACKGROUND

Stents act as scaffoldings, functioning to physically hold open and, ifdesired, to expand the wall of the passageway of a target vessel. Stentsare often used in the treatment of atherosclerotic stenosis and/orrestenosis in blood vessels. “Stenosis” refers to a narrowing orconstriction of the diameter of a bodily passage or orifice. Typically,stents are capable of being compressed, so that they can be insertedthrough small cavities via catheters, and then expanded to a largerdiameter once they reach their target vessel. Mechanical interventionvia stents has reduced the rate of restenosis; restenosis, however, isstill a significant clinical problem. “Restenosis” refers to thereoccurrence of stenosis in a blood vessel or heart valve after it hasbeen treated (as by balloon angioplasty or valvuloplasty) with apparentsuccess. Accordingly, stents have been modified to perform not only as amechanical scaffolding, but also to provide biological therapy.

Biological therapy can be achieved by medicating a stent, typicallyreferred to as a drug delivery stent. Drug delivery stents provide forthe local administration of a therapeutic substance at the diseasedsite. In contrast, systemic administration of a therapeutic substancemay cause adverse or toxic side effects for the patient because largedoses are needed in order for the therapeutic substance to have anefficacious effect at the diseased site. Thus, local delivery is apreferred method of treatment in that smaller total levels of medicationare administered in comparison to systemic dosages, but are concentratedat a specific site. Local delivery therefore produces fewer side effectsand achieves more favorable results.

A typical method for medicating an implantable device includes, forexample, applying a composition containing a polymer, a solvent, and atherapeutic substance to the implantable device using conventionaltechniques, such as spray-coating or dip-coating. The method furtherincludes removing the solvent, leaving on the implantable device surfacea coating of the polymer with the therapeutic substance impregnated inthe polymer.

In a typical spray-coating method, a stent is mounted on a mandrel of aspray-coating device. Generally, the stent will rest on, or contactcomponents of, a mandrel (or the mandrel itself) which supports thestent and allows it to rotate during a spray-coating process. Thecontact between the portions of the mandrel and stent, however,inevitably cause coating defects. These defects can include cob-webbing,tearing, bridging, clumping and/or lack of coating on portions of thestent. The embodiments of the present invention are intended to addresscoating defect issues caused by conventional mandrel designs.

SUMMARY

Apparatuses, methods for the manufacture thereof and methods for coatinga stent without using a mandrel are herein disclosed.

According to some embodiments, an implantable medical device, comprisinga body and a severable support element connected to the body to supportthe body during the formation of a coating on at least a portion of thedevice such that the severable support element can be severed subsequentto the formation of the coating, may be coated without use of a mandrelon a spray-coating device

According to one form of a method of manufacture, an apparatus may befabricated by making a stent having a severable support elementconnected thereto for supporting the stent during the process of forminga coating on the stent.

According to one form of a method, a method of coating a stent includesproviding a stent having a severable support element attached thereto,depositing a coating on the stent and breaking the severable supportelement to remove all of or a portion of the severable support elementfrom the stent.

Other objects and advantages of the present invention will become moreapparent to those persons having ordinary skill in the art to which thepresent invention pertains from the foregoing description taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary stent.

FIG. 2 illustrates a method of coating a conventional stent with aspray-coating device.

FIG. 3 illustrates an enlarged view of an embodiment of a stent with aseverable end tube at a distal end of the stent of the presentinvention.

FIG. 3A is a blown up view of a stent strut of the stent of FIG. 3.

FIG. 4 illustrates an enlarged view of an alternative embodiment of astent with a severable tab at a distal end of the stent of the presentinvention.

FIG. 5 illustrates an enlarged view of an alternative embodiment of astent with a severable tab at a center ring of the stent of the presentinvention.

FIG. 6 illustrates a method of coating a stent of the present inventionwith a spray-coating device.

FIG. 7 illustrates a cross-sectional view of a tailstock which can beused pursuant to a method of coating a stent of the present invention.

FIG. 8 illustrates another method of coating a stent of the presentinvention with a spray-coating device.

DETAILED DESCRIPTION

The implantable medical device used in conjunction with the presentinvention may be any implantable medical device, examples of whichinclude self-expandable stents, balloon-expandable stents, micro-depotor micro-channel stents, stent-grafts and grafts. Examples of stentsinclude neurological, coronary, peripheral and urological stents. Insome embodiments, the underlying structure of the implantable medicaldevice can be virtually any design.

FIG. 1 illustrates a stent 10, which in various embodiments may bemetallic or polymeric. In either form, the stent 10 can include aplurality of struts 12 linked by connecting elements 14, with the struts12 and connecting elements 14 surrounding or partially surroundinginterstitial spaces 16. The plurality of struts 12 can be configured inan annular fashion in discrete “rows” such that they form a series of“rings” throughout the body of the stent 10. Thus, the stent 10 caninclude a proximal ring 18, a distal ring 20 and at least one centralring 22.

FIG. 2 illustrates a spray-coating device 100 that can be used to coat astent of the present invention. The spray-coating device 100 can includethe following elements: a stent movement and rotating device 102, asupport member 104 and a stent holding device 106 for rotation andmovement of the stent 10 before, during and/or after the coatingprocess; a nozzle 108 with an air shroud device 110 for spray-coatingthe stent 10; and an exhaust system 112 to remove excess spray from thetarget area on the stent 10. In some applications, the stent 10 can bemounted onto the stent holding device 106 forming an assembly thereof.The assembly can then be mounted into a socket of the support member 104for coating with composition 114 from the air shroud 110 of the nozzle108. In some applications, the stent movement and rotating device 102can move the assembly in a linear direction (arrow 116) to achieve atargeted or uniform coating. In some applications, the support member104 can rotate the assembly (arrow 118) to achieve a targeted or uniformcoating. In some applications, a combination of linear and rotationalmovements can be used to coat the stent 10. The exhaust system 112 canfunction to remove excess composition during the spray-coating process.In the spray-coating method just described, contact areas between thestent 10 and the stent holding device 106 can cause defects in thecoating in the form of cob-webbing, tearing, bridging, clumping and/orlack of coating on portions of the stent.

FIG. 3 illustrates one embodiment of a stent of the present invention.In this embodiment, the stent 10 includes a plurality of struts 12linked by connecting elements 14, with the struts 12 and connectingelements 14 surrounding or partially surrounding interstitial spaces 16.The stent 10 also includes a proximal ring 18 (not shown), a distal ring20 and at least one central ring 22. The stent 10 of the presentinvention can include a “severable portion” or attachment to someportion of the stent 10 and severable at least one “gate”, flange or bar26, terms which are used interchangeably unless otherwise usedspecifically. The severable portion or support element can include atleast one end tube, at least one tab or any combination thereof. In someembodiments, an end tube 24 is attached to a sidewall 30 of a stentstrut 12 of the distal ring 20 by at least one thin gate 26. Generally,the gate 26 may be attached to the side wall 30, an inner surface 32, anouter surface 34 or any combination thereof of the stent 10 (see FIG.3A).

In some embodiments, the stent 10 and the end tube 24 can be monolithic.That is, when the stent pattern is originally cut or etched from a flatsheet or from a tube, the end portion(s) of the pattern remains attachedto the stent pattern by the at least one gate 26 (or attachment 36). Theend portion(s) therefore can function as an end tube(s) 24. Stentpatterns can be formed by a variety of methods, including but notlimited to, laser cutting and etching, such as chemical etching. Otherstent pattern formation techniques may be utilized and are known bythose skilled in the art.

In some embodiments, the end tube 24 may be attached to the stent by asecondary process, such as, for example, by biocompatible glue orsolder. In the process in which the stent pattern is cut into a flatsheet (as opposed to directly on a tube), the attaching may be doneeither after the cutting or after the cut pattern is rolled into a tubeforming a stent thereof. In some embodiments, the severable portion caninclude a tab 28 attached to some portion of the stent 10 (see FIGS. 4and 5). Thus FIG. 4 illustrates an alternative embodiment in which thetab 28A is attached to the sidewall 30 (not shown in this figure) of thedistal ring 20 of the stent 10 by a gate 26. FIG. 5 illustrates yetanother alternative embodiment in which the tab 28B is attached to atleast one central ring 22 by an attachment 36. In any embodiment, thetabs 28 can be attached monolithically or by secondary processes asexplained in relation to the embodiment incorporating an end tube 24.Therefore, the at least one gate 26 (or attachment 36) with tube 24 ortab 28 can be made from the same material as the stent 10 or made ofdifferent material. In some embodiments, the material for the gate 26,the tube 24, and the tab 28 can be any of the polymeric and/or metallicmaterials disclosed below. For example, the gate 26 can be made of thepolymers from which the stent is made and/or coated.

The end portion(s) of the stent 10, which may be at least one end tube24 or at least one tab 28, function to support the stent on aspray-coating device (such as those illustrated in FIGS. 2, 6 and 8)before, during or after the spray-coating process and optionally adrying stage. Thus, the end portion(s) are severable via the at leastone gate 26 (or attachment 36) which is attached to some portion of thestent 10. The gate(s) 26 (or attachment 36) can be very thin so that itcan be easily removed after a spray-coating process. For example, thethickness (or width) of gate 26 (or attachment 36) can be between0.0005″ and 0.0035″, typically 0.002″. In some embodiments, gates 26 (orattachment 36) can be perforated about a width segment thereof so as tofacilitate breaking off of the gates 26 (or attachment 36) from stent10. Such perforation can be positioned along any surface of the gate 26(or attachment 36) 10, such as adjacent to the sidewall 30, such that noportion of the gate 26 (or attachment 36) is left behind after thebreaking thereof. In addition, the number of gates can number betweenone and ten, typically two. Because the weight of the stent is very low(between 1 mg and 50 mg), the number of gates should be minimized toreduce any rough areas caused by severing the end portion(s) at the atleast one gate(s) 26 (or attachment 36) after a spray-coating process.

FIG. 6 illustrates one form of a method using the stent described inFIG. 3 with a modified version of the spray-coating device 100 of FIG.2. In some embodiments, the end tube 24 can be inserted into a circularopening 40 of a tail stock 38 (see FIG. 7). The tail stock 38 can becylindrical and between 0.25 inches and 1.0 inch, preferably 0.5 inchesin diameter. In addition, the tail stock can be metal, polymer or anycombination thereof. The opening 40 can function to secure the end tube24 or tab 28 when the support member 104 is rotating during aspray-coating process (explained below). The tail stock 38 canthereafter be mounted onto the support member 104. Alternatively, thetail stock 38 can be mounted on the support member 104, and the end tube24 or the tab 28 can thereafter be inserted into the tail stock 38. Insome embodiments, the end tube 24 can be press-fitted directly onto thesupport member 104. After positioning, the stent 10 can then be coatedby composition 114 from nozzle 108. In some applications, the stentmovement and rotating device 102 can move the stent 10 in a lineardirection (arrow 116) to achieve a partial or uniform coating. In someapplications, the support member 104 can rotate the stent 10 (arrow 118)to achieve a partial or uniform coating. In some applications, acombination of linear and rotational movements can be used to coat thestent 10. Other spray-coating techniques known by those skilled in theart can also be used.

After the spray-coating process (or optional drying process), the endtubes 24 (or end tabs 28) may be detached by mechanically breaking,chemically severing, a combination of mechanical/chemical processing, orlaser cutting the at least one gate 26 (or attachment 36) at the stent10 or at some portion, or junction, along the at least one gate 26 (orattachment 36). Preferably, detachment is made adjacent to or at thesurface of the stent with no portions or minimal portions of the gate 26(or attachment 36) left behind. In some embodiments, detachment can beaccomplished by holding the stent 10 and rotating the tube 24 (orvice-versa) with sufficient torque. Additional polishing or touch uptechniques at those break points can be implemented to remove anyremaining portions of the gate 26 (or attachment 36) or any roughnesscaused by the breaking of the at least one gate 26 (or attachment 36).For example, the break points may be contacted briefly with solvent tosmooth out the break points. Examples of solvents which can be usedinclude, but are not limited to, acetone, methyl ethyl ketone ortetrahydrofuran. This smoothing technique is most beneficial if the gate26 (or attachment 36) is made from a polymer (e.g., bioabsorbable orbiostable polymer disclosed below). Alternatively, a solvent for thepolymer can be used to remove or etch away gate 26 (or attachment 36).The solvent, however, should not adversely affect the coating, theintegrity of the stent 10 or any therapeutic agent contained on orwithin stent 10.

FIG. 8 illustrates another apparatus and form of a method pursuant tothe present invention using a spray-coating device 200. Thespray-coating device illustrated in this embodiment may be used tospray-coat, for example, long stents, which stents may require supporton both the distal end 18 and proximal end 20 provided by an end tube 24or an end tab 28. For example, a coronary stent in the range of 5.0 mmto 50.0 mm may be coated pursuant to this method. The spray-coatingdevice 200 can include a first support member 208 with coning region216A and a second support member 210 with coning region 216B forsupporting the tail stocks 38. First support member 208 may connect to amotor 206 to provide rotational motion about the longitudinal axis of astent (depicted by arrow 224). Another motor 204 may also be providedfor moving device 200 in a back-and-forth linear direction along rail202 (depicted by arrow 222). The types and specifications of the variousmotors which can be used in any of the embodiments herein would beapparent to those skilled in the art.

Spray-coating device 200 can include a support arm 212 to support thenon-motor end of the stent 10. The support arm 212 allows the stent 10to remain level without any deflection that can be caused by weight. Insome embodiments, the support arm 212 can be in slidable communicationwith the rail 202 to allow linear movement of the stent 10. Bearings canbe used so that rotational movement of the stent 10 by the support arm212 is not hindered. In some embodiments, at least two tail stocks 38can be mounted onto the coning region 216A of the first support member208 and the coning region 216B of the second support member 210. Thestent 10 with end tubes 24 can then be inserted into the openings 40 ofthe tail stocks 38, respectively. Alternatively, the end tubes 24 may besecured over or onto the coning regions 216A and 216B of the first andsecond supporting members 208 and 210, respectively. The nozzle 218 thenapplies a composition 226 which can be applied while the stent is movedrotationally (arrow 224), linearly (arrow 222), or any combinationthereof, by the spray-coating device 200. After the spray-coatingprocess, the end tubes 24 (or end tabs 28) may be removed by breakingthe at least one gate 26 (or attachment 36). It is preferred that thecoating be dry before removal of the gate 26 (or attachment 36).Additional polishing or touch up at those break points can beimplemented to remove any roughness caused by the breaking of the atleast one gate 26 (or attachment 36). For example, the break points maybe contacted briefly with solvent to smooth out the break points.

Advantageously, the stents of the present invention eliminate the needfor a stent holding device, such as a mandrel, in the spray-coatingprocess. That is, the end tubes 24 or end tabs 28 provide support to thestent when mounted on a spray-coating device, eliminating the need forsupport that would otherwise be provided by the mandrel. In this manner,coating defects caused by contact between the stent 10 and the mandrelare thereby substantially or completely eliminated. The end tubes 24 orend tabs 28 are severable from the stent 10 by gate(s) 26 (orattachment(s) 36) so that they are not part of the drug delivery stentfinal product. In some embodiments, at least a part of or the entiregate 26 (or attachment 36) can be included as the stent final product,such that these elements can be regarded as struts. It is, however,preferred that any portion of the gate 26 (or attachment 36) be removedand polished.

The stent 10 can be made of a metallic material or an alloy such as, butnot limited to, stainless steel (316L or 300), “MP35N,” “MP2ON,”ELASTINITE (Nitinol), Egiloy, tantalum, tantalum alloy, cobalt-chromiumalloy, nickel-titanium alloy, platinum, iridium, platinum-iridium alloy,gold, magnesium, or combinations thereof. “MP35N” and “MP2ON” are tradenames for alloys of cobalt, nickel, chromium and molybdenum availablefrom standard Press Steel Co., Jenkintown, Pa. “MP35N” consists of 35%cobalt, 35% nickel, 20% chromium, and 10% molybdenum. “MP2ON” consistsof 50% cobalt, 20% nickel, 20% chromium, and 10% molybdenum.

The stent 10 may also be made from and/or coated with a biostablepolymer or a bioerodable, biodegradable, bioadsorbable polymer or anycombination thereof. Bioerodable, biodegradable or bioadsorbable areintended to be used interchangeably unless otherwise indicated. Also,the stent inner diameter (“ID”) can range anywhere between two mm tofour mm for coronary stents and five mm to twenty mm for peripheralstents. In some embodiments, a polymeric stent can include othermaterials, such as layers or deposits of metallic material which can bebioerodable.

Representative examples of polymers which may comprise a polymeric stentand/or a coating thereon are, but are not limited to, fluorinatedpolymers or copolymers such as poly(vinylidene fluoride),poly(vinylidene fluoride-co-hexafluoro propene),poly(tetrafluoroethylene), and expanded poly(tetrafluoroethylene);poly(sulfone); poly(N-vinyl pyrrolidone); poly(aminocarbonates);poly(iminocarbonates); poly(anhydride-co-imides), poly(hydroxyvalerate);poly(L-lactic acid); poly(L-lactide); poly(caprolactones);poly(lactide-co-glycolide); poly(hydroxybutyrates);poly(hydroxybutyrate-co-valerate); poly(dioxanones); poly(orthoesters);poly(anhydrides); poly(glycolic acid); poly(glycolide); poly(D,L-lacticacid); poly(D,L-lactide); poly(glycolic acid-co-trimethylene carbonate);poly(phosphoesters); poly(phosphoester urethane); poly(trimethylenecarbonate); poly(iminocarbonate); poly(ethylene); and any derivatives,analogs, homologues, congeners, salts, copolymers and combinationsthereof.

In some embodiments, the polymers include, but are not limited to,poly(propylene) co-poly(ether-esters) such as, for example,poly(dioxanone) and poly(ethylene oxide)/poly(lactic acid);poly(anhydrides), poly(alkylene oxalates); poly(phosphazenes);poly(urethanes); silicones; poly(esters); poly(olefins); copolymers ofpoly(isobutylene); copolymers of ethylene-alphaolefin; vinyl halidepolymers and copolymers such as poly(vinyl chloride); poly(vinyl ethers)such as, for example, poly(vinyl methyl ether); poly(vinylidene halides)such as, for example, poly(vinylidene chloride); poly(acrylonitrile);poly(vinyl ketones); poly(vinyl aromatics) such as poly(styrene);poly(vinyl esters) such as poly(vinyl acetate); co-polymers of vinylmonomers and olefins such as poly(ethylene-co-vinyl alcohol) (EVAL);co-polymers of acrylonitrile-styrene, ABS resins, and copolymers ofethylene-vinyl acetate; and any derivatives, analogs, homologues,congeners, salts, copolymers and combinations thereof.

In some embodiments, the materials can also include, but are not limitedto, poly(amides) such as Nylon 66 and poly(caprolactam); alkyd resins;poly(carbonates); poly(oxymethylenes); poly(imides); poly(ester amides);poly(ethers) including poly(alkylene glycols) such as, for example,poly(ethylene glycol) and poly(propylene glycol); epoxy resins;polyurethanes; rayon; rayon-triacetate; biomolecules such as, forexample, fibrin, fibrinogen, starch, poly(amino acids); peptides,proteins, gelatin, chondroitin sulfate, dermatan sulfate (a co-polymerof D-glucuronic acid or L-iduronic acid and N-acetyl-D-galactosamine),collagen, hyaluronic acid, and glycosaminoglycans; other polysaccharidessuch as, for example, poly(N-acetylglucosamine), chitin, chitosan,cellulose, cellulose acetate, cellulose butyrate, cellulose acetatebutyrate, cellophane, cellulose nitrate, cellulose propionate, celluloseethers, and carboxymethylcellulose; and any derivatives, analogs,homologues, congeners, salts, copolymers and combinations thereof.

In some embodiments, the polymer can be a poly(ester amide), apoly(lactide) or a poly(lactide-co-glycolide) copolymer; and anyderivatives, analogs, homologues, congeners, salts, copolymers andcombinations thereof.

In some embodiments, the biodegradable polymers can include, but are notlimited to, polymers having repeating units such as, for example, anα-hydroxycarboxylic acid, a cyclic diester of an α-hydroxycarboxylicacid, a dioxanone, a lactone, a cyclic carbonate, a cyclic oxalate, anepoxide, a glycol, an anhydride, a lactic acid, a glycolic acid, alactide, a glycolide, an ethylene oxide, an ethylene glycol, and anyderivatives, analogs, homologues, congeners, salts, copolymers andcombinations thereof.

In some embodiments, the biodegradable polymers include, but are notlimited to, polyesters, poly(ester amides); poly(hydroxyalkanoates)(PHA), amino acids; PEG and/or alcohol groups; polycaprolactones,poly(D-lactide), poly(L-lactide), poly(D,L-lactide), poly(meso-lactide),poly(L-lactide-co-meso-lactide), poly(D-lactide-co-meso-lactide),poly(D,L-lactide-co-meso-lactide), poly(D,L-lactide-co-PEG) blockcopolymers, poly(D,L-lactide-co-trimethylene carbonate), polyglycolides,poly(lactide-co-glycolide), polydioxanones, polyorthoesters,polyanhydrides, poly(glycolic acid-co-trimethylene carbonate),polyphosphoesters, polyphosphoester urethanes, poly(amino acids),polycyanoacrylates, poly(trimethylene carbonate), poly(imino carbonate),polycarbonates, polyurethanes, copoly(ether-esters) (e.g. PEO/PLA),polyalkylene oxalates, polyphosphazenes, PHA-PEG, and any derivatives,analogs, homologues, salts, copolymers and combinations thereof.

In other embodiments, the polymers can be poly(glycerol sebacate);tyrosine-derived polycarbonates containing desaminotyrosyl-tyrosinealkyl esters such as, for example, desaminotyrosyl-tyrosine ethyl ester(poly(DTE carbonate)); and any derivatives, analogs, homologues, salts,copolymers and combinations thereof.

In some embodiments, the polymers are selected such that theyspecifically exclude any one or any combination of any of the polymerstaught herein.

The stents described herein may be coated with one or more therapeuticagents, including an anti-proliferative, anti-inflammatory or immunemodulating, anti-migratory, anti-thrombotic or other pro-healing agentor a combination thereof. The anti-proliferative agent can be a naturalproteineous agent such as a cytotoxin or a synthetic molecule or othersubstances such as actinomycin D, or derivatives and analogs thereof(manufactured by Sigma-Aldrich 1001 West Saint Paul Avenue, Milwaukee,Wis. 53233; or COSMEGEN available from Merck) (synonyms of actinomycin Dinclude dactinomycin, actinomycin IV, actinomycin I1, actinomycin X1,and actinomycin C1), all taxoids such as taxols, docetaxel, andpaclitaxel, paclitaxel derivatives, all olimus drugs such as macrolideantibiotics, rapamycin, everolimus, structural derivatives andfunctional analogues of rapamycin, structural derivatives and functionalanalogues of everolimus, FKBP-12 mediated mTOR inhibitors, biolimus,perfenidone, prodrugs thereof, co-drugs thereof, and combinationsthereof. Representative rapamycin derivatives include40-O-(3-hydroxy)propyl-rapamycin,40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, or 40-O-tetrazole-rapamycin,40-epi-(N1-tetrazolyl)-rapamycin (ABT-578 manufactured by AbbotLaboratories, Abbot Park, Ill.), prodrugs thereof, co-drugs thereof, andcombinations thereof.

The anti-inflammatory agent can be a steroidal anti-inflammatory agent,a non-steroidal anti-inflammatory agent, or a combination thereof. Insome embodiments, anti-inflammatory drugs include, but are not limitedto, alclofenac, alclometasone dipropionate, algestone acetonide, alphaamylase, amcinafal, amcinafide, amfenac sodium, amiprilosehydrochloride, anakinra, anirolac, anitrazafen, apazone, balsalazidedisodium, bendazac, benoxaprofen, benzydamine hydrochloride, bromelains,broperamole, budesonide, carprofen, cicloprofen, cintazone, cliprofen,clobetasol propionate, clobetasone butyrate, clopirac, cloticasonepropionate, cormethasone acetate, cortodoxone, deflazacort, desonide,desoximetasone, dexamethasone dipropionate, diclofenac potassium,diclofenac sodium, diflorasone diacetate, diflumidone sodium,diflunisal, difluprednate, diftalone, dimethyl sulfoxide, drocinonide,endrysone, enlimomab, enolicam sodium, epirizole, etodolac, etofenamate,felbinac, fenamole, fenbufen, fenclofenac, fenclorac, fendosal,fenpipalone, fentiazac, flazalone, fluazacort, flufenamic acid,flumizole, flunisolide acetate, flunixin, flunixin meglumine, fluocortinbutyl, fluorometholone acetate, fluquazone, flurbiprofen, fluretofen,fluticasone propionate, furaprofen, furobufen, halcinonide, halobetasolpropionate, halopredone acetate, ibufenac, ibuprofen, ibuprofenaluminum, ibuprofen piconol, ilonidap, indomethacin, indomethacinsodium, indoprofen, indoxole, intrazole, isoflupredone acetate,isoxepac, isoxicam, ketoprofen, lofemizole hydrochloride, lomoxicam,loteprednol etabonate, meclofenamate sodium, meclofenamic acid,meclorisone dibutyrate, mefenamic acid, mesalamine, meseclazone,methylprednisolone suleptanate, momiflumate, nabumetone, naproxen,naproxen sodium, naproxol, nimazone, olsalazine sodium, orgotein, orpanoxin, oxaprozin, oxyphenbutazone, paranyline hydrochloride, pentosanpolysulfate sodium, phenbutazone sodium glycerate, pirfenidone,piroxicam, piroxicam cinnamate, piroxicam olamine, pirprofen,prednazate, prifelone, prodolic acid, proquazone, proxazole, proxazolecitrate, rimexolone, romazarit, salcolex, salnacedin, salsalate,sanguinarium chloride, seclazone, sermetacin, sudoxicam, sulindac,suprofen, talmetacin, talniflumate, talosalate, tebufelone, tenidap,tenidap sodium, tenoxicam, tesicam, tesimide, tetrydamine, tiopinac,tixocortol pivalate, tolmetin, tolmetin sodium, triclonide,triflumidate, zidometacin, zomepirac sodium, aspirin (acetylsalicylicacid), salicylic acid, corticosteroids, glucocorticoids, tacrolimus,pimecorlimus, prodrugs thereof, co-drugs thereof, and combinationsthereof.

These agents can also have anti-proliferative and/or anti-inflammatoryproperties or can have other properties such as antineoplastic,antiplatelet, anti-coagulant, anti-fibrin, antithrombonic, antimitotic,antibiotic, antiallergic, antioxidant as well as cystostatic agents.Examples of suitable therapeutic and prophylactic agents includesynthetic inorganic and organic compounds, proteins and peptides,polysaccharides and other sugars, lipids, and DNA and RNA nucleic acidsequences having therapeutic, prophylactic or diagnostic activities.Nucleic acid sequences include genes, antisense molecules which bind tocomplementary DNA to inhibit transcription, and ribozymes. Some otherexamples of other bioactive agents include antibodies, receptor ligands,enzymes, adhesion peptides, blood clotting factors, inhibitors or clotdissolving agents such as streptokinase and tissue plasminogenactivator, antigens for immunization, hormones and growth factors,oligonucleotides such as antisense oligonucleotides and ribozymes andretroviral vectors for use in gene therapy. Examples of antineoplasticsand/or antimitotics include methotrexate, azathioprine, vincristine,vinblastine, fluorouracil, doxorubicin hydrochloride (e.g. Adriamycin®from Pharmacia & Upjohn, Peapack N.J.), and mitomycin (e.g. Mutamycin®from Bristol-Myers Squibb Co., Stamford, Conn.). Examples of suchantiplatelets, anticoagulants, antifibrin, and antithrombins includesodium heparin, low molecular weight heparins, heparinoids, hirudin,argatroban, forskolin, vapiprost, prostacyclin and prostacyclinanalogues, dextran, D-phe-pro-arg-chloromethylketone (syntheticantithrombin), dipyridamole, glycoprotein IIb/IIIa platelet membranereceptor antagonist antibody, recombinant hirudin, thrombin inhibitorssuch as Angiomax ä (Biogen, Inc., Cambridge, Mass.), calcium channelblockers (such as nifedipine), colchicine, fibroblast growth factor(FGF) antagonists, fish oil (omega 3-fatty acid), histamine antagonists,lovastatin (an inhibitor of HMG-CoA reductase, a cholesterol loweringdrug, brand name Mevacor® from Merck & Co., Inc., Whitehouse Station,N.J.), monoclonal antibodies (such as those specific forPlatelet-Derived Growth Factor (PDGF) receptors), nitroprusside,phosphodiesterase inhibitors, prostaglandin inhibitors, suramin,serotonin blockers, steroids, thioprotease inhibitors,triazolopyrimidine (a PDGF antagonist), nitric oxide or nitric oxidedonors, super oxide dismutases, super oxide dismutase mimetic,4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), estradiol,anticancer agents, dietary supplements such as various vitamins, and acombination thereof. Examples of such cytostatic substance includeangiopeptin, angiotensin converting enzyme inhibitors such as captopril(e.g. Capoten® and Capozide® from Bristol-Myers Squibb Co., Stamford,Conn.), cilazapril or lisinopril (e.g. Prinivil® and Prinzide® fromMerck & Co., Inc., Whitehouse Station, N.J.). An example of anantiallergic agent is permirolast potassium. Other therapeuticsubstances or agents which may be appropriate include alpha-interferon,and genetically engineered epithelial cells. The foregoing substancesare listed by way of example and are not meant to be limiting. Otheractive agents which are currently available or that may be developed inthe future are equally applicable. In some embodiments, any one of thestent 10, the gate 26 (or attachment 36), the end tube 24 or tab 38 canbe made of the same material or different materials, such as any of theabove-described materials.

From the foregoing detailed description, it will be evident that thereare a number of changes, adaptations and modifications of the presentinvention which come within the province of those skilled in the art.The scope of the invention includes any combination of the elements fromthe different species or embodiments disclosed herein, as well assubassemblies, assemblies, and methods thereof. However, it is intendedthat all such variations not departing from the spirit of the inventionbe considered as within the scope thereof.

What is claimed is:
 1. A method comprising: providing a monolithicdevice comprising a stent and a severable support element; engaging theseverable support element to a device configured to move the stent;followed by depositing a polymeric coating on the stent while theseverable support element is engaged to the device, wherein thepolymeric coating comprises one or more therapeutic agents that exhibitantiproliferative, antiinflammatory, immune modulating, antimigratoric,antineoplastic, antiplateletic, anticoagulantic, antifibrinic,antithrombonic, antimitotic, antibiotic, antiallergic, antioxidant,cystostatic effects; exhibit other pro-healing effects; or exhibit anycombination of these effects; and followed by removing at least aportion of the severable support element from the stent wherein removingincludes using a mechanical technique, wherein the removed portion ofthe severable support element is not part of any stent final product. 2.The method of claim 1, wherein the device configured to move the stentis without a mandrel for holding the stent.
 3. The method of claim 1,further comprising removing roughness at an area of the stent where theportion of the several support element was removed.
 4. The method ofclaim 1, wherein the depositing of the polymeric coating is performedwhile the device, which is engaged to the element, rotates the elementand the stent.
 5. A method comprising: providing a stent connected to aseverable support element; depositing a coating on the stent while thestent is connected to the element; and followed by severing the stentfrom the element including removing at least a portion of the elementfrom the stent after depositing the coating, wherein the removed portionof the element is not part of any stent final product, the depositing ofthe coating is performed while the element is connected to a device andwhile the device moves the element and the stent, and the device iswithout a mandrel for holding the stent.
 6. A method comprising:providing a stent connected to a severable support element; depositing acoating on the stent while the stent is connected to the element,wherein the depositing of the coating is performed while the element isconnected to a device configured to move the stent, and the deviceconfigured to move the stent is without a mandrel for holding the stent;and severing the stent from the element including removing at least aportion of the element from the stent after depositing the coating,wherein the removed portion of the element is not part of any stentfinal product, and the providing step comprises: manufacturing the stentsuch that the element is a monolithic extension of the stent, orattaching the element to the stent by an adhesive or other material. 7.The method of claim 6 wherein the entire element is removed from thestent.
 8. The method of claim 6 additionally comprising, prior todepositing the coating, supporting the stent on the device configured tomove the stent by engaging the element with the device.
 9. The method ofclaim 6 wherein removing comprises mechanical, chemical or laser removaltechniques.
 10. The method of claim 6 wherein removing comprisesapplying a solvent that dissolves or etches the element from the stent.11. The method of claim 6 wherein the element includes an arm connectedto a tab or a tube, and wherein the method additionally comprisesengaging the tab or the tube to the device configured to move the stent.12. The method of claim 6 wherein the element includes an arm configuredto break from the stent or to break along a segment of the arm.
 13. Themethod of claim 6 wherein the element includes an arm havingperforations wherein the arm is configured to break along theperforations.
 14. The method of claim 6 wherein the stent connects tothe element with an adhesive or by soldering.
 15. The method of claim 6wherein the providing step comprises manufacturing the stent such thatthe element is a monolithic extension of the stent.
 16. The method ofclaim 6 wherein the stent comprises a polymer, a metal, or a polymer.17. The method of claim 6 wherein the stent comprises one or moretherapeutic agents, and wherein the one or more therapeutic agentsexhibit antiproliferative, antiinflammatory, immune modulating,antimigratoric, antineoplastic, antiplateletic, anticoagulantic,antifibrinic, antithrombonic, antimitotic, antibiotic, antiallergic,antioxidant, or cystostatic effects; exhibit other pro-healing effects;or exhibit any combination of these effects.
 18. The method of claim 6,further comprising removing roughness at an area of the stent where theportion of the element was removed.
 19. A method comprising: providing astent connected to a severable support element; depositing a coating onthe stent while the stent is connected to the element, wherein thedepositing of the coating is performed while a device is engaged withthe element and while the device rotates the element and the stent;severing the stent from the element including removing at least aportion of the element from the stent after depositing the coating; andpolishing an area of the stent where the element was removed.
 20. Amethod comprising: providing a stent connected to a severable supportelement; depositing a coating on the stent while the stent is connectedto the element; and severing the stent from the element includingremoving at least a portion of the element from the stent afterdepositing the coating, wherein the removed portion of the element isnot part of any stent final product, and the providing step comprises:manufacturing the stent such that the element is a monolithic extensionof the stent, or attaching the element to the stent by an adhesive orother material; wherein the method additionally comprising, prior todepositing the coating, supporting the stent on a device configured tomove the stent by engaging the element with the device, and wherein thedepositing of the coating is performed while the device, which isengaged with the element, rotates the element and the stent.